Guide to Parallel Imports - Human Medicines
05 March 2013
This guide applies to nationally-authorised products which are parallel-imported from another Member State of the EU or an EEA country and distributed on the Irish market. In order to legally place such a product on the Irish market a parallel import licence is required and the IMB operates two schemes in this regard. Where the product to be imported differs in any respect from that on the Irish market, a parallel import licence (termed a ‘parallel product authorisation’) must be obtained. – see section 2 below. Where the product to be imported is identical in all respects (including identical packaging, labels and leaflets) to the product on the Irish market, a parallel import licence (termed a dual pack import registration (DPR)) is required.
The framework for these schemes is that set out in Commission Communication Parallel Imports of Proprietary Medicinal Products for which Marketing Authorisations have already been granted (COM(2003)839). The simplified procedures in this Guide are in accordance with the procedure in the Communication in terms of the information required to be submitted by applicants and the administrative steps to be taken by the IMB.
Products which are centrally-authorised by the European Commission are not covered by this guide; importers wishing to parallel distribute these products must notify the EMEA and the IMB of their intention. For details of the notification system, see http://www.ema.europa.eu/htms/human/parallel/parallel.htm.
Please note that applicants are required to make all related documentation (including approval letters) received from the EMA available to the IMB during an inspection.
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Guide to Parallel Imports - Human Medicines
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